Clene Stock Jumps After FDA Opens Door to Fast-Track ALS Drug Filing
Clene plans to seek accelerated FDA approval for its ALS drug CNM-Au8 in the third quarter of 2026, after meeting minutes indicated its data may support an NDA. Shares rose to $6.94, up 80 cents, after touching $9.74. The FDA asked for more evidence linking biomarker reductions to clinical benefit. A Phase 3 confirmatory trial is set for early 2027.